BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM DIA COCR MOD HD +3MM NK

    MDR report key: 7286962 · Received February 21, 2018

    Report

    Report Number
    0001825034-2018-00795
    Event Type
    Injury
    Date Received
    February 21, 2018
    Date of Event
    December 12, 2017
    Report Date
    October 2, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK911684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION IDENTIFIED THAT THE HEAD WAS STILL ATTACHED TO THE STEM AND FURTHER DIMENSIONAL ANALYSIS WAS NOT COMPLETED. A DIMENSIONAL ANALYSIS WAS PERFORMED ON THE OVERALL WIDTH OF RINGLOC BIPOLAR AND WAS CONFIRMING TO PRINT SPECIFICATIONS. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICES: 11-165220, RINGLOC BI-POLAR 28X48MM, 429310, 650-0463, B.FX STEM HA COL D 13X145MM T1, 3781405. REPORT SOURCE, FOREIGN - THE EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 00796.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED APPROXIMATELY ONE MONTH POST IMPLANTATION DUE TO LUXATION IN BIPOLAR HEAD. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130301 28MM DIA COCR MOD HD +3MM NK PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A J6040930

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R